CLIA Laboratory and Medical Director (Part time)

SAGA Diagnostics recently established a US operation in Research Triangle Park (RTP) and is excited to invite you to join our dedicated team.

The CLIA Laboratory and Medical Director is responsible for ensuring the delivery of quality clinical laboratory services. This position will serve as the CLIA Laboratory Director and be listed on the CLIA license. Specific responsibilities will include histology slide assessment, tissue selection, molecular assay interpretation and sign-out, assay development and validation, participation in laboratory operations, and improving digital pathology capabilities.

Essential Duties and Responsibilities:

• Responsibilities in operating the histopathology laboratory under CLIA, CAP, NYS, and all other applicable regulations.
• Responsible for slide review for tumor content estimation, diagnosis correlation, and communication with referring pathologists and oncologists if discrepancies arise.
• Participation in the quality management system, management of adverse outcomes and non-conformities, participation in onsite surveys, appropriate management of the results of the on-site survey, and performance in proficiency testing.
• Provide oversight of all aspects of the laboratory’s quality management system to ensure conformance to requirements described in the Quality Management System chapter of the Clinical Laboratory Practice Standards.
• Provide continuing education to laboratory technical staff that is relevant to laboratory medicine.
• Ensure that policies and procedures are established for monitoring staff to assess competency and, whenever necessary, provide remedial training or continuing education to improve skills.
• Promote a safe laboratory environment for personnel and the public.
• Ensure that an approved procedure manual is available to all personnel.
• Monitor all work performed in the laboratory to ensure that medically reliable data are generated.
• Assure that the laboratory participates in monitoring and evaluating the quality and appropriateness of services rendered, within the context of the Quality Management System, regardless of where the testing is performed.
• Provide advice to referring physicians regarding the significance of laboratory findings and ensure that reports of test results include pertinent information required for specific patient interpretation.
• Effectively implement a plan of correction for deficiencies identified.
• Report all concerns of test quality and/or safety to Supervisor or Safety Officer.
• Review and approve laboratory documentation such as policies and procedures, validation plans and reports, training and competency assessments, and reagent/control/instrument qualifications, quality audits, deviation approval requests, and nonconforming event reports.

• Must be a licensed physician in North Carolina (or be eligible for licensure).
• Must possess training and demonstrated expertise in histopathology, obtained within the previous six years, in generally accepted and currently used methods and techniques in one or more categories listed below, and must meet one of the following requirements:
• Be a physician who is currently certified by the American Board of Pathology in Anatomic Pathology and Clinical Pathology and preferably an area of special competence relevant to molecular genetics.
• Must be qualified for New York State in the categories of Oncology and Histopathology or able to obtain said qualification.
• Board certification by the American Board of Pathology in Molecular Genetic Pathology, or equivalent, is a plus.

• Competitive Compensation and company wide benefits plan
• Opportunities for career advancement and professional development.
• A collaborative and innovative work environment dedicated to improving oncology outcomes.

If you require reasonable accommodation in completing an application, interviewing, or otherwise participating in the employee selection process, please direct your inquiries to hr@sagadiagnostics.com.